Title:
Stagiaire CMC Regulatory Strategy
Company:
Ipsen Innovation (SAS)
About Ipsen:
Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.
Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram .
Job Description:
Position Summary
Within the Global Regulatory CMC ( Chemistry , manufacturing and controls) team (belonging to Regulatory affairs , part of R&D organization) , the intern will contribute to the optimization, digitalization, and exploitation of regulatory data to support operational excellence, knowledge management, and submission readiness across the Regulatory CMC organization.
The intern will work on practical business projects covering data analytics and visualization, regulatory intelligence, process automation and digital knowledge management.
Key Responsibilities
1-Development of a Regulatory CMC Onboarding SharePoint Platform
Design and implement a dedicated SharePoint site to support onboarding of new Regulatory CMC team members.
Ensure the platform serves as a sustainable knowledge management repository for the team.
Continuously improve the SharePoint site based on user feedback and evolving business needs.
2-Development of Data Analytics and Performance Monitoring Tools
Analyze existing data sources from multiple regulatory systems and databases.
Design and implement data consolidation and visualization solutions using Power BI, advanced Excel, Power Query, Power Automate, and other digital tools.
Identify opportunities to improve data quality, reliability, accessibility, and reporting efficiency.
Explore opportunities to automate and improve the visualization of workload, capacity and resource forecasts.
Support the development of data-driven resource and capacity forecasting tools, using historical workload, project characteristics and activity assumptions to improve resource planning.
3-Regulatory Intelligence, AI and Predictive Analytics
Analyze historical Health Authority questions and regulatory requests across multiple products and regions.
Identify trends, recurring topics, and risk factors associated with regulatory submissions.
Explore the use of AI, machine learning and advanced analytics to identify patterns within regulatory data and knowledge repositories.
Propose predictive tools and methodologies to anticipate potential Health Authority questions during future submissions.
Contribute to the development of a regulatory knowledge repository to facilitate dossier preparation and regulatory strategy planning.
4-Digitalization and Process Improvement Initiatives
Support Regulatory CMC digital transformation projects, including the implementation and optimization of Veeva and other regulatory systems.
Identify automation opportunities to streamline regulatory processes and reduce manual work.
Contribute to continuous improvement initiatives focused on operational efficiency and knowledge management.
Assist the team in adopting new digital tools and best practices
Support good data governance practices, including data quality, consistency, traceability and appropriate use of regulatory information when developing digital solutions.
Candidate Profile
Final-year student pursuing a…